Validation of Different Methods for HepQuant DuO® Blood Sample Collection

NCT07473817 | Not Yet Recruiting

• 1 other identifier: HQ-US-2501
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study to see the agreement of blood samples collected through different means and tube types for the HepQuant DuO Test. The HepQuant DuO Test is a blood-based test that involves a drink of a natural compound, cholate, and blood samples at 20 and 60 minutes. The study team is collecting clinical and laboratory data from patients living with chronic liver disease and healthy adult volunteers. The study has up to 2 study visits at an outpatient clinic and can take up to 4 weeks for a participant to complete study. At these visits, participants will undergo a HepQuant DuO test and other standard lab tests. In addition, the study team will ask about a participant's experience with different blood sampling methods.

Conditions

Healthy Adult Participants; Liver Disease Chronic

Outcome Measures

Primary Outcomes (1)

• Difference in d4-cholate concentrations between RTs by VP (reference method) and the SSTs by VP (primary index method).

  To evaluate the agreement of the HepQuant DuO 20- and 60-minute d4-cholate concentrations between samples collected using Serum Separator Tubes (SST) by venipuncture (VP) (the primary index method) and blood collection in Red-top Tubes (RTs) by VP (the reference method).

  From screening to completion of blood collection at Visit 1 is 2 weeks.

Study Arms (1)

Blood Sampling

Participant completes a HepQUant DuO test during which the participant ingests a d4-tagged cholate solution and has blood samples drawn 20 and 60 minutes after ingesting oral solution. Blood samples are obtained through direct venipuncture of a peripheral vein, one is collected into a red-top tube and one is collected into a serum separator tube (SST), and simultaneously, a third blood sample is collected into Microtainer SST using a transcutaneous capillary blood collection device.

Device: HepQuant DuO Test

Interventions

HepQuant DuO Test DEVICE

HepQuant DuO is commercially available in the U.S. as a Laboratory Developed Test (LDT), but it will be used in this study as a nonsignificant risk investigational device to measure change in liver function over time.

Blood Sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants ranging from healthy to living with chronic liver disease will consist of: 50% healthy participants 25% CLD participants with non-cirrhotic fibrosis 25% CLD participants with cirrhosis of which no more than 10% of the total study participants will have Child-Pugh class of B or C.

You may qualify if:

• adult healthy participant with no major comorbidities and lean body mass (BMI 18-25.5)
• adult participant with all etiologies of parenchymal chronic liver disease or PBC or PSC with F2-F3 fibrosis or cirrhosis.

You may not qualify if:

• under the age of 18
• pregnancy
• Unable to absorb orally administered cholate (examples could include underlying severe gastroparesis or having undergone extensive small bowel resection, conditions or post-operative state that could impair the absorption of the orally administered d4-cholate)
• NPO (nothing through the mouth) status or those who are unable to ingest a thin liquid by mouth
• for patients with cirrhosis, any hospital admission within 3 months of enrollment in the study.

Sponsors & Collaborators

• HepQuant, LLC: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum from blood samples.

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): April 20, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share